Gabapentin API USP39
Product Name: Gabapentin
Synonyms:NEURONTIN;GABAPENTINE;GABAPENTIN;HYDROCHLORIDE;GABAPENTIN;GOE-3450;(1-AMINOMETHYL-CYCLOHEXYL)-ACETIC ACID;
1-(AMINOMETHYL)CYCLOHEXANEACETIC ACID;AKOS 92109
CAS: 60142-96-3
MF: C9H17NO2
MW: 171.24
EINECS: 262-076-3
Chemical Properties: White Crystalline Solid
Uses: Amino acid structurally related to γ-Aminobutyric Acid (GABA), designed to cross the blood brain barrier. Used as an anticonvulsant. antipsychotic, 5HT2A antagonist. selective H1- receptor antagonist. For the treatment of adult Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).
Gabapentin (GPN), marketed under the brand name Neurontin among others, is a medication used to treat epilepsy, neuropathic pain, hot flashes, and restless leg syndrome. In epilepsy it may be used for those with partial seizures. It is recommended as one of a number of first line medications for the treatment of neuropathic pain in diabetic neuropathy, post-herpetic neuralgia, and central neuropathic pain. A 2017 review of its use for diabetic neuropathy and postherpetic neuralgia found that about 15% of people have a meaningful benefit.
Gabapentin / Neurontin USP39 Pharma Materials Chemical Tests (COA) :
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Test items
Items of analysis
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Standard
Specification
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Result
Results
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appearance
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white crystalline powder
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white crystalline powder
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identification
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IR spectrum should comply with the CRS
HPLC-RT should comply with the CRS
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conform
conform
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PH
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6.5-8.0
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7.2
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water
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not more than 0.5%
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0.0%
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resiude on ignition
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not more than 0.1%
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0.0%
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heavy metals
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not more than 0.02%
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less than 0.002%
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impurity A
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not more than 0.1%
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<0.02%
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impurity B
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not more than 0.06%
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<0.02%
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impurity E
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not more than 0.1%
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<0.02%
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impurity CDMA
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not more than 0.1%
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<0.02%
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max individual unknown impurity
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not more than 0.1%
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<0.03%
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impurity D
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not more than 0.1%
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<0.02%
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impurity CAI
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not more than 0.1%
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<0.02%
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max individual unknown impurity
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not more than 0.1%
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<0.02%
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total impurity
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not more than 0.5%
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0.0%
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methanol
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not more than 3000ppm
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55ppm
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isopropanol
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not more than 5000ppm
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52ppm
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methylene chloride
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not more than 600ppm
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N.D
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toluene
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not more than 890ppm
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N.D
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assay
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98.0%~102.0%
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99.4%
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Conclusion
Conclusion
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Qualified
Qualified
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